Elastic Compression Stockings for Prevention of Post-thrombotic Syndrome
NCT ID: NCT01578122
Last Updated: 2020-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
350 participants
INTERVENTIONAL
2012-06-29
2019-06-28
Brief Summary
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ECS with a lighter compression strength (20-30mmHg) might be easier to apply and be more comfortable. This could favor a better compliance.
CELEST is a randomized, multicentre, double-blind trial which aims to determine whether ECS applying 25mmHg of targeted pressure at the ankle are non inferior to ECS applying 35mmHg of targeted pressure at the ankle
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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25mmHg ECS
Thigh-length graduated elastic compression stockings applying 25mmhg of targeted pressure at the ankle worn daily for two years
25mmHg ECS
Thigh-length graduated elastic compression stockings applying 25 mmhg of targeted pressure at the ankle worn daily (from morning to night) for two years.
Before receiving the randomly allocated treatment, each patient will wear cotton, class III Varisma Comfort® stay-up stockings (20-36 mm Hg).
35mmHg ECS
Thigh-length graduated elastic compression stockings applying 35 mmhg of targeted pressure at the ankle worn daily for two years
35 mmHg ECS
Thigh-length graduated elastic compression stockings applying 35mmhg of pressure at the ankle worn daily (from morning to night) for two years Before receiving the randomly allocated treatment, each patient will wear cotton, class III Varisma Comfort® stay-up stockings (20-36 mm Hg).
Interventions
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25mmHg ECS
Thigh-length graduated elastic compression stockings applying 25 mmhg of targeted pressure at the ankle worn daily (from morning to night) for two years.
Before receiving the randomly allocated treatment, each patient will wear cotton, class III Varisma Comfort® stay-up stockings (20-36 mm Hg).
35 mmHg ECS
Thigh-length graduated elastic compression stockings applying 35mmhg of pressure at the ankle worn daily (from morning to night) for two years Before receiving the randomly allocated treatment, each patient will wear cotton, class III Varisma Comfort® stay-up stockings (20-36 mm Hg).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient presenting with an initial episode of proximal deep vein thrombosis (DVT) confirmed by an additional examination (echo-Doppler scan) taken no more than 8 days previously :
the proximal character defined by a DVT from the collecting trunk extending from the tibial-peroneal trunk to the inferior vena cava inclusive the unilateral character concerns only the proximal part. Patients with a distal DVT on the contralateral member the day of diagnosis can be included The notion of initial episode concerns only the proximal part. Patients with a preceding DVT limited to distal part can be included
* with no trophic disorders at baseline (CEAP class 4, 5 or 6 excluded)
* with or without pulmonary embolism
* Patient capable of benefiting from anticoagulant therapy of at least 3 months duration
* Available to participate in a clinical trial with a 24-month follow-up period and for which a delivery of study products may be possible throughout its participation (delivery possible only in Metropolitan France)
* Life expectancy greater than 24 months
* Volunteer to take part in the study, having signed the consent form after receiving sufficient information and the information leaflet
* Person affiliated to social security or the recipient of a similar scheme.
* Patients with at least one of these contraindications to compression treatment:
* phlegmasia cerulea dolens,
* septic thrombosis,
* product intolerance, allergic reaction to one of the components
* Arteritis obliterans stage III and IV of the lower limbs (IPS\<0.6),
* Micro-angiopathy, advanced diabetes,
* Decompensated heart failure,
* Skin infections: anti-infective treatment must precede compression therapy,
* Weeping skin diseases of the leg.
* Compression treatment technically impossible during the study
* Patients presenting with bilateral venous thrombosis of the lower limbs.
* Patient having received fibrinolytic treatment, mechanical thrombo-aspiration or venous repermeation surgery for venous thrombosis justifying inclusion
* Patients having undergone mechanical interruption of the inferior vena cava.
* Patients for whom long-term elastic compression for the treatment of lymphatic venous insufficiency (patients with lymphoedema), for instance, is indicated prior to DVT. Patients with elastic compression for primary thromboprophylaxis of thromboembolic disease (TED) are eligible.
* Patients presenting with oedema unrelated to venous insufficiency or in whom oedema is likely to develop within 2 years.
* Patients receiving diuretic treatment for more than 3 months due to heart failure.
* Pregnant women
* Person deprived of liberty by a legal or administrative decision, person under legal protection.
* Patient currently participating in a clinical trial or having taken part in a clinical trial in the month preceding inclusion
* Patient presenting with a history of mental or psychiatric illness or any other factor restricting his/her ability to participate in an informed manner and in compliance with the protocol
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Floralis
INDUSTRY
Laboratoires Innothera
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Luc BOSSON, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CIC Grenoble
Locations
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Cabinet
Lyon, Rhônes Alpes, France
Cabinet
Aix-les-Bains, , France
Cabinet
Alençon, , France
Clinique Victor PAUCHET
Amiens, , France
CHRU Amiens
Amiens, , France
Cabinet
Amiens, , France
Chu Angers
Angers, , France
Cabinet
Annecy, , France
Chra Annecy
Annecy, , France
Centre Hospitalier d'Armentieres
Armentières, , France
CH Armentières
Armentières, , France
Cabinet
Bordeaux, , France
Cabinet
Bourgoin, , France
Ch Bourgoin-Jallieu
Bourgoin, , France
Hia Brest
Brest, , France
Chu Brest
Brest, , France
CHU
Caen, , France
Cabinet
Carcassonne, , France
Cabinet
Chalon-sur-Saône, , France
Ch Chalon Sur Saone
Chalon-sur-Saône, , France
CH de Chambéry
Chambéry, , France
Cabinet
Clapiers, , France
Chu Clermont-Ferrand
Clermont-Ferrand, , France
CHU Gabriel Montpied
Clermont-Ferrand, , France
Cabinet
Dijon, , France
Hôpital du bocage
Dijon, , France
Cabinet
Échirolles, , France
Cabinet
Genas, , France
Cabinet
Grenoble, , France
Chu Grenoble
Grenoble, , France
Cabinet
Hennebont, , France
Cabinet
Issy-les-Moulineaux, , France
Ch La Rochelle
La Rochelle, , France
Cabinet
Lille, , France
Chru Lille
Lille, , France
Hopital Saint Philibert
Lomme, , France
CH Pierre-Bénite
Lyon, , France
CH Mâcon
Mâcon, , France
Cabinet
Montbonnot-Saint-Martin, , France
Cabinet
Montélimar, , France
Cabinet
Montigny-lès-Metz, , France
Cabinet
Montluçon, , France
Chu Montpellier
Montpellier, , France
Chu Hotel Dieu
Nantes, , France
CHR Orléans
Orléans, , France
HEGP
Paris, , France
Hôpital St Joseph
Paris, , France
Cabinet
Péronne, , France
Cabinet
Saint-Alban, , France
Cabinet
Saint-Aubin-sur-Scie, , France
Chu St Etienne
Saint-Etienne, , France
Cabinet
Sélestat, , France
Cabinet
Thonon-les-Bains, , France
Chu Toulouse
Toulouse, , France
Cabinet
Tournefeuille, , France
Cabinet
Villeurbanne, , France
Cabinet
Vizille, , France
Countries
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References
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Fowkes FJ, Price JF, Fowkes FG. Incidence of diagnosed deep vein thrombosis in the general population: systematic review. Eur J Vasc Endovasc Surg. 2003 Jan;25(1):1-5. doi: 10.1053/ejvs.2002.1778.
Oger E. Incidence of venous thromboembolism: a community-based study in Western France. EPI-GETBP Study Group. Groupe d'Etude de la Thrombose de Bretagne Occidentale. Thromb Haemost. 2000 May;83(5):657-60.
Prandoni P, Kahn SR. Post-thrombotic syndrome: prevalence, prognostication and need for progress. Br J Haematol. 2009 May;145(3):286-95. doi: 10.1111/j.1365-2141.2009.07601.x. Epub 2009 Feb 13.
Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996 Jul 1;125(1):1-7. doi: 10.7326/0003-4819-125-1-199607010-00001.
Prandoni P, Villalta S, Bagatella P, Rossi L, Marchiori A, Piccioli A, Bernardi E, Girolami B, Simioni P, Girolami A. The clinical course of deep-vein thrombosis. Prospective long-term follow-up of 528 symptomatic patients. Haematologica. 1997 Jul-Aug;82(4):423-8.
Gabriel F, Labios M, Portoles O, Guillen M, Corella D, Frances F, Martinez M, Gil J, Saiz C. Incidence of post-thrombotic syndrome and its association with various risk factors in a cohort of Spanish patients after one year of follow-up following acute deep venous thrombosis. Thromb Haemost. 2004 Aug;92(2):328-36. doi: 10.1160/TH03-11-0700.
Kahn SR, Ginsberg JS. Relationship between deep venous thrombosis and the postthrombotic syndrome. Arch Intern Med. 2004 Jan 12;164(1):17-26. doi: 10.1001/archinte.164.1.17.
Kahn SR, Hirsch A, Shrier I. Effect of postthrombotic syndrome on health-related quality of life after deep venous thrombosis. Arch Intern Med. 2002 May 27;162(10):1144-8. doi: 10.1001/archinte.162.10.1144.
Bergqvist D, Jendteg S, Johansen L, Persson U, Odegaard K. Cost of long-term complications of deep venous thrombosis of the lower extremities: an analysis of a defined patient population in Sweden. Ann Intern Med. 1997 Mar 15;126(6):454-7. doi: 10.7326/0003-4819-126-6-199703150-00006.
Brandjes DP, Buller HR, Heijboer H, Huisman MV, de Rijk M, Jagt H, ten Cate JW. Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet. 1997 Mar 15;349(9054):759-62. doi: 10.1016/S0140-6736(96)12215-7.
Prandoni P, Lensing AW, Prins MH, Frulla M, Marchiori A, Bernardi E, Tormene D, Mosena L, Pagnan A, Girolami A. Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med. 2004 Aug 17;141(4):249-56. doi: 10.7326/0003-4819-141-4-200408170-00004.
Milne AA, Ruckley CV. The clinical course of patients following extensive deep venous thrombosis. Eur J Vasc Surg. 1994 Jan;8(1):56-9. doi: 10.1016/s0950-821x(05)80121-5.
Partsch H, Blattler W. Compression and walking versus bed rest in the treatment of proximal deep venous thrombosis with low molecular weight heparin. J Vasc Surg. 2000 Nov;32(5):861-9. doi: 10.1067/mva.2000.110352.
Kahn SR, Elman E, Rodger MA, Wells PS. Use of elastic compression stockings after deep venous thrombosis: a comparison of practices and perceptions of thrombosis physicians and patients. J Thromb Haemost. 2003 Mar;1(3):500-6. doi: 10.1046/j.1538-7836.2003.00098.x.
Benko T, Cooke EA, McNally MA, Mollan RA. Graduated compression stockings: knee length or thigh length. Clin Orthop Relat Res. 2001 Feb;(383):197-203.
Sajid MS, Tai NR, Goli G, Morris RW, Baker DM, Hamilton G. Knee versus thigh length graduated compression stockings for prevention of deep venous thrombosis: a systematic review. Eur J Vasc Endovasc Surg. 2006 Dec;32(6):730-6. doi: 10.1016/j.ejvs.2006.06.021. Epub 2006 Aug 23.
Nelson EA, Harper DR, Prescott RJ, Gibson B, Brown D, Ruckley CV. Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression. J Vasc Surg. 2006 Oct;44(4):803-8. doi: 10.1016/j.jvs.2006.05.051.
Arpaia G, Cimminiello C, Mastrogiacomo O, de Gaudenzi E. Efficacy of elastic compression stockings used early or after resolution of the edema on recanalization after deep venous thrombosis: the COM.PRE Trial. Blood Coagul Fibrinolysis. 2007 Mar;18(2):131-7. doi: 10.1097/MBC.0b013e328011f2dd.
Roumen-Klappe EM, den Heijer M, van Rossum J, Wollersheim H, van der Vleuten C, Thien T, Janssen MC. Multilayer compression bandaging in the acute phase of deep-vein thrombosis has no effect on the development of the post-thrombotic syndrome. J Thromb Thrombolysis. 2009 May;27(4):400-5. doi: 10.1007/s11239-008-0229-7. Epub 2008 May 15.
Delluc A, Gouedard C, De Saint Martin L, Garcia C, Roguedas AM, Bressollette L, Misery L, Mottier D, Le Gal G. [Incidence, risk factors and skin manifestations of post-thrombotic syndrome: a four-year follow-up of patients included in the EDITH study]. Rev Med Interne. 2010 Nov;31(11):729-34. doi: 10.1016/j.revmed.2010.07.018. Epub 2010 Sep 29. French.
Galanaud JP, Genty-Vermorel C, Barrellier MT, Becker F, Jabbour V, Blaise S, Bura-Riviere A, Comte A, Grange C, Guenneguez H, Maufus M, Ouvry P, Richaud C, Rolland C, Schmidt J, Sevestre MA, Verriere F, Bosson JL; CELEST trial investigators. 25 mm Hg versus 35 mm Hg elastic compression stockings to prevent post-thrombotic syndrome after deep vein thrombosis (CELEST): a randomised, double-blind, non-inferiority trial. Lancet Haematol. 2022 Dec;9(12):e886-e896. doi: 10.1016/S2352-3026(22)00247-2.
Other Identifiers
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2010-A01078-31
Identifier Type: OTHER
Identifier Source: secondary_id
CVE301-10 (Themas) : DCIC/1028
Identifier Type: -
Identifier Source: org_study_id
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